Late-stage biopharmaceutical company Cytokinetics Inc. (CYTK:NASDAQ) today announced "positive topline results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of CK-3773274 (CK-274), an investigational next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM)."
Cytokinetics is engaged in developing medicines to treat debilitating cardiovascular and neuromuscular diseases of impaired muscle function, such as HCM, amyotrophic lateral sclerosis (ALS), heart failure (HF) and spinal muscular atrophy (SMA). The company indicated that it believes that the results demonstrated in the REDWOOD-HCM study are sufficient to go forward with its Phase 3 CK-274 registrational clinical trial as planned by year-end 2021.
The company reported that the data gathered from 41 total patients enrolled in Cohorts 1 and 2 in the REDWOOD-HCM study showed that following 10 weeks of treatment with CK-274, participants achieved statistically significant reductions in both the average resting left ventricular outflow tract pressure gradient and the average post-Valsalva LVOT versus the control group.
The company's E.V.P. of Research & Development Fady I. Malik, M.D., Ph.D., stated, "The combined data from Cohorts 1 and 2 in REDWOOD-HCM met our high expectations for this trial of CK-274 in patients with obstructive HCM, given the observed onset of response to initiation of treatment, magnitude and breadth of response, reversibility of LVEF decreases and favorable tolerability profile…These findings inform the design of our Phase 3 trial, in which we expect to titrate patients with a flexible dosing scheme of 5, 10, 15, and 20 mg to personalize and maximize the potential treatment effect for patients."
Marty Maron, M.D., director of the Hypertrophic Cardiomyopathy Center and director of cardiac CT and MRI at Tufts University School of Medicine, and principal investigator of REDWOOD-HCM, commented, "We are pleased to see the impressive results in terms of substantial reduction of outflow tract gradient from REDWOOD-HCM and the clinically relevant combination of efficacy and safety findings and reversibility of effect evident from treatment with CK-274…We look forward to seeing how these results may translate into a clinically meaningful impact on patients' symptoms and exercise tolerance in Phase 3."
The company noted that REDWOOD-HCM is a 17-site, randomized trial of CK-274 in patients with symptomatic obstructive HCM (oHCM). The study's main goals are to evaluate the safety and tolerability of CK-274 as well as to determine the optimum dosage levels for treatment based upon escalating doses of once daily administered CK-274. The firm indicated that "the secondary objectives are to describe the concentration-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment, to describe the dose response relationship of CK-274, and to evaluate the plasma concentrations of CK-274 in patients with oHCM."
The firm indicated that its own scientists discovered CK-274 in-house, which it described as a novel, oral, small molecule cardiac myosin inhibitor that is thought to reduce the hypercontractility associated with HCM.
The company explained that "HCM is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied)." The firm elaborated noting that when the cardiac muscle thickens it affects the left ventricle's ability to fill and pump blood naturally. Cytokinetics advised that symptoms of HCM include chest pain, dizziness, fainting during physical activity and shortness of breath.
Cytokinetics is headquartered in South San Francisco, Calif., and is a late-stage biopharmaceutical company working to discover, develop and commercialize muscle activators and inhibitors to treat debilitating muscular diseases. The firm stated that in addition to its work on developing CK-274 for HCM indications, "it is preparing a U.S. NDA submission of omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure." Cytokinetics is also concurrently engaged in developing a fast skeletal muscle troponin activator called reldesemtiv as a potential ALS treatment.
Cytokinetics started the day with a market cap of around $1.4 billion with approximately 71.74 million shares outstanding and a short interest of about 11.4%. CYTK shares opened 45% higher today at $27.91 (+$8.68, +45.14%) over yesterday's $19.23 closing price and reached a new 52-week high this morning of $31.41. The stock has traded today between $26.70 and $31.41 per share and is currently trading at $27.02 (+$7.79, +40.51%).[NLINSERT]
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